Spectrum Pharmaceuticals Reports Financial Results for First Quarter 2013

  Spectrum Pharmaceuticals Reports Financial Results for First Quarter 2013

  *Total revenue for the three months ending March 31, 2013 was $38.7
    million. The company recorded a GAAP EPS of ($0.05).
  *Pivotal data in relapsed/refractory peripheral T-cell lymphoma from
    late-stage drug Belinostat to be presented as an oral presentation at ASCO
    2013; the company expects to submit an NDA this summer.
  *Company expects enrollment in the Captisol-enabled® melphalan study in
    multiple myeloma to be completed in 2013, with NDA submission in 2014.
  *$163.4 million cash, cash equivalents, and investments as of March 31,
    2013, as compared to $143.0 million as of December 31, 2012.

Business Wire

HENDERSON, Nev. -- May 09, 2013

Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully
integrated commercial and drug development operations with a primary focus in
hematology and oncology, announced today financial results for the three-month
period ended March 31, 2013.

“As a diversified company with three marketed oncology products and a maturing
pipeline, I am proud to say Spectrum is well positioned for future growth,”
said Rajesh C. Shrotriya, M.D., Chairman, President and Chief Executive
Officer of Spectrum Pharmaceuticals, Inc. “We intend to continue to strengthen
and build our internal capabilities, while exercising fiscal discipline. We
believe the potential launches of additional products such as belinostat and
Captisol-enabled melphalan will further diversify our base business and
provide catalysts for near-term growth. Further, we continue to advance our
investigational products such as SPI-2012, SPI-1620, apaziquone and ZEVALIN^®
(ibritumomab tiuxetan) in Diffuse Large B-Cell Lymphoma, each of which, if
approved by the FDA, could have a significant impact on our long-term growth.
Spectrum has a successful track record of strategic business development, and
continues to seek opportunities that will benefit patients and our
shareholders.”

Three-Month Period Ended March 31, 2013 (All numbers are approximate)

GAAP Results

Consolidated revenue of $38.7 million was comprised of net product sales of
$29.3 million and $9.3 million from licensing fees. This represents a 35.4%
decrease from the $59.9 million in consolidated revenue, including net product
sales of $56.8 million, recorded in the three-month period ending March 31,
2012.

Product revenues in first quarter included: FUSILEV® (levoleucovorin) net
sales of $11.8 million, FOLOTYN® (pralatrexate injection) net sales of $9.9
million and ZEVALIN® (ibritumomab tiuxetan) net sales of $7.6 million.

The Company recorded net loss of $2.8 million, or ($0.05) per basic and
diluted share in the three-month period ended March 31, 2013, compared to a
net income of $46.5 million, or $0.80 per basic and $0.71 per diluted share in
the comparable period in 2012. Total research and development expenses were
$12.0 million in the quarter, as compared to $8.9 million in the same period
in 2012. Selling, general and administrative expenses were $22.3 million in
the quarter, compared to $18.3 million in the same period in 2012.

Non-GAAP Results

The Company recorded non-GAAP net loss of $3.4 million, or ($0.06) per basic
and diluted share in the three-month period ended March 31, 2013, compared to
a net income of $27.0 million, or $0.46 per basic and $0.41 per diluted share
in the comparable period in 2012. Non-GAAP license and contract revenues in
the three month period ended March 31, 2013 of $3.1 million do not include
license revenue of $6.2 million from Allergan in connection with the amendment
to the agreement. Non-GAAP research and development adjustments were $1.8
million, as compared to $1.4 million in the same period of 2012. Non-GAAP
selling, general and administrative adjustments were $2.4 million, as compared
to $3.7 million in the same period in 2012.

During the three-month period ended March 31, 2013, net cash provided by
operations was approximately $21.6 million. Cash, cash equivalents, and
investments as of March 31, 2013 were $163.4 million, as compared to $143.0
million as of December 31, 2012.

There were approximately 60.0 million shares of common stock issued and
outstanding as of March 31, 2013.

Conference Call

     Thursday, May 9, 2013 @ 1:30 p.m. Eastern/10:30 a.m. Pacific
          
          Domestic: (877) 837-3910, Conference ID# 34586964
          
          International: (973) 796-5077, Conference ID# 34586964
          

This conference call will also be webcast. Listeners may access the webcast,
which will be available on the investor relations page ofSpectrum
Pharmaceutical’s website: www.sppirx.com onMay 9, 2013at1:30
p.m.Eastern/10:30 a.m.Pacific.

On the conference call, management will review the financial results, provide
an update on the Company's business and discuss expectations for the future.

Key Potential Growth Catalysts

  *Pivotal Data from belinostat in relapsed/refractory PTCL to be presented
    as an oral presentation at ASCO 2013
  *Belinostat NDA submission in summer 2013
  *Pivotal data and Captisol-enabled melphalan NDA submission in 2014
  *Apaziquone NDA submission in 2014
  *Continued progress of Spectrum-sponsored or supported ZEVALIN studies,
    including

       *Phase 3 ZEST clinical trial in patients with Diffuse Large B-Cell
         Lymphoma (DLBCL)
       *An international investigator initiated study, the SPINOZA trial in
         patients with relapsed DLBCL who receive autologous stem cell
         transplantation (ASCT)

About Spectrum Pharmaceuticals, Inc.

Spectrum Pharmaceuticals is a leading biotechnology company focused on
acquiring, developing, and commercializing drug products, with a primary focus
in oncology and hematology. Spectrum and its affiliates market three oncology
drugs ─ FUSILEV^® (levoleucovorin) for Injection in the U.S.; FOLOTYN^®
(pralatrexate injection), also marketed in the U.S.; and ZEVALIN^®
(ibritumomab tiuxetan) Injection for intravenous use, for which the Company
has worldwide marketing rights. Spectrum's strong track record in in-licensing
and acquiring differentiated drugs, and expertise in clinical development have
generated a robust, diversified, and growing pipeline of product candidates in
advanced-stage Phase 2 and Phase 3 studies. More information on Spectrum is
available at www.sppirx.com.

About FUSILEV^® (levoleucovorin) for injection

FUSILEV, a novel folate analog, is approved as a ready-to-use solution
(FUSILEV Injection), and as freeze-dried powder (FUSILEV for Injection).
FUSILEV is indicated for use in combination chemotherapy with 5-fluorouracil
in the palliative treatment of patients with advanced metastatic colorectal
cancer. FUSILEV is also indicated for rescue after high-dose methotrexate
therapy in osteosarcoma. FUSILEV is also indicated to diminish the toxicity
and counteract the effects of impaired methotrexate elimination and of
inadvertent overdosage of folic acid antagonists. FUSILEV, under various trade
names, is marketed outside the United States by Pfizer, Sanofi-Aventis, and
Takeda.

Important FUSILEV^® (levoleucovorin) Safety Considerations

FUSILEV is dosed at one-half the usual dose of racemic d,l-leucovorin. FUSILEV
is contraindicated for patients who have had previous allergic reactions
attributed to folic acid or folinic acid. Due to calcium content, no more than
16-mL (160-mg) of levoleucovorin solution should be injected intravenously per
minute. FUSILEV enhances the toxicity of fluorouracil. Concomitant use of
d,l-leucovorin with trimethoprim-sulfamethoxazole for pneumocystis carinii
pneumonia in HIV patients was associated with increased rates of treatment
failure in a placebo-controlled study. Allergic reactions were reported in
patients receiving FUSILEV. Vomiting (38%), stomatitis (38%) and nausea (19%)
were reported in patients receiving FUSILEV as rescue after high dose
methotrexate therapy. The most common adverse reactions ( > 50%) in patients
with advanced colorectal cancer receiving FUSILEV in combination with
5-fluorouracil were diarrhea, nausea and stomatitis. FUSILEV may counteract
the antiepileptic effect of phenobarbital, phenytoin and primidone, and
increase the frequency of seizures in susceptible patients.

Full prescribing information for FUSILEV can be found at www.FUSILEV.com.

About ZEVALIN^® and the ZEVALIN Therapeutic Regimen

ZEVALIN (ibritumomab tiuxetan) injection for intravenous use, is indicated for
the treatment of patients with relapsed or refractory, low-grade or follicular
B-cell non-Hodgkin's lymphoma (NHL). ZEVALIN is also indicated for the
treatment of patients with previously untreated follicular non-Hodgkin's
Lymphoma who achieve a partial or complete response to first-line
chemotherapy.

ZEVALIN is a CD20-directed radiotherapeutic antibody. The ZEVALIN therapeutic
regimen consists of two components: rituximab, and Yttrium-90 (Y-90)
radiolabeled ZEVALIN for therapy. ZEVALIN builds on the combined effect of a
targeted biologic monoclonal antibody augmented with the therapeutic effects
of a beta-emitting radioisotope.

Important ZEVALIN^® Safety Information

Deaths have occurred within 24 hours of rituximab infusion, an essential
component of the ZEVALIN therapeutic regimen. These fatalities were associated
with hypoxia, pulmonary infiltrates, acute respiratory distress syndrome,
myocardial infarction, ventricular fibrillation, or cardiogenic shock. Most
(80%) fatalities occurred with the first rituximab infusion. ZEVALIN
administration can result in severe and prolonged cytopenias in most patients.
Severe cutaneous and mucocutaneous reactions, some fatal, can occur with the
ZEVALIN therapeutic regimen.

Please see full Prescribing Information, including BOXED WARNINGS, for ZEVALIN
and rituximab. Full prescribing information for ZEVALIN can be found at
www.ZEVALIN.com.

About FOLOTYN^®

FOLOTYN, (pralatrexate injection), a folate analogue metabolic inhibitor, was
discovered by Memorial Sloan-Kettering Cancer Center, SRI International and
Southern Research Institute and developed by Allos Therapeutics. In September
2009, the U.S. Food and Drug Administration (FDA) granted accelerated approval
for FOLOTYN for use as a single agent for the treatment of patients with
relapsed or refractory PTCL. This indication is based on overall response
rate. Clinical benefit such as improvement in progression-free survival or
overall survival has not been demonstrated. FOLOTYN has been available to
patients in the U.S. since October 2009. An updated analysis of data from
PROPEL, the pivotal study of FOLOTYN in patients with relapsed or refractory
PTCL, was published in the March 20, 2011 issue of the Journal of Clinical
Oncology. FOLOTYN has patent protection through July 2022, based on a
five-year patent term extension through the Hatch-Waxman Act.

Important FOLOTYN^® Safety Information

Warnings and Precautions

FOLOTYN may suppress bone marrow function, manifested by thrombocytopenia,
neutropenia, and anemia. Monitor blood counts and omit or modify dose for
hematologic toxicities.

Mucositis may occur. If greater-than or equal to Grade 2 mucositis is
observed, omit or modify dose. Patients should be instructed to take folic
acid and receive vitamin B12 to potentially reduce treatment-related
hematological toxicity and mucositis.

Fatal dermatologic reactions may occur. Dermatologic reactions may be
progressive and increase in severity with further treatment. Patients with
dermatologic reactions should be monitored closely, and if severe, FOLOTYN
should be withheld or discontinued. Tumor lysis syndrome may occur. Monitor
patients and treat if needed.

FOLOTYN can cause fetal harm. Women should avoid becoming pregnant while being
treated with FOLOTYN and pregnant women should be informed of the potential
harm to the fetus.

Use caution and monitor patients when administering FOLOTYN to patients with
moderate to severe renal function impairment.

Elevated liver function test abnormalities may occur and require monitoring.
If liver function test abnormalities are greater-than or equal to Grade 3,
omit or modify dose.

Adverse Reactions

The most common adverse reactions were mucositis (70%), thrombocytopenia
(41%), nausea (40%), and fatigue (36%). The most common serious adverse events
are pyrexia, mucositis, sepsis, febrile neutropenia, dehydration, dyspnea, and
thrombocytopenia.

Use in Specific Patient Population

Nursing mothers should be advised to discontinue nursing or the drug, taking
into consideration the importance of the drug to the mother.

Drug Interactions

Co-administration of drugs subject to renal clearance (e.g., probenecid,
NSAIDs, and trimethoprim/sulfamethoxazole) may result in delayed renal
clearance.

Please see FOLOTYN Full Prescribing Information at www.FOLOTYN.com.

About Captisol-Enabled Melphalan

Captisol-enabled^®, PG-free melphalan is a intravenous formulation of
melphalan being investigated for the multiple myeloma transplant setting,
which has been granted Orphan drug designation by the FDA. This formulation
avoids the use of propylene glycol, which has been reported to cause renal and
cardiac side effects that limit the ability to deliver higher doses of
therapeutic compounds. The use of the Captisol technology to reformulate
melphalan is anticipated to allow for longer administration durations and
slower infusion rates, potentially enabling clinicians to safely achieve a
higher dose intensity of pre-transplant chemotherapy.

In December 2012, a pivotal trial of Captisol-enabled melphalan was initiated.
This multi-center trial is evaluating safety and efficacy in 60 patients, and
is intended to confirm the results from an earlier Phase 2 study demonstrating
that the Captisol-enabled melphalan formulation showed acceptable safety
findings, and met the requirements for establishment of bioequivalence to the
current commercial intravenous formulation of melphalan (sold by
GlaxoSmithKline as Alkeran® for Injection).

About Captisol®

Captisol is a patent-protected, chemically modified cyclodextrin with a
structure designed to optimize the solubility and stability of drugs. Captisol
was invented and initially developed by scientists in the laboratories of Dr.
Valentino Stella at the University of Kansas' Higuchi Biosciences Center for
specific use in drug development and formulation, and is owned by Ligand
Pharmaceuticals.

Forward-looking statement — This press release may contain forward-looking
statements regarding future events and the future performance of Spectrum
Pharmaceuticals that involve risks and uncertainties that could cause actual
results to differ materially. These statements are based on management's
current beliefs and expectations. These statements include, but are not
limited to, statements that relate to our business and its future, including
sales of Spectrum’s drug products, certain company milestones, Spectrum's
ability to identify, acquire, develop and commercialize a broad and diverse
pipeline of late-stage clinical and commercial products, leveraging the
expertise of partners and employees around the world to assist us in the
execution of our strategy, and any statements that relate to the intent,
belief, plans or expectations of Spectrum or its management, or that are not a
statement of historical fact. Risks that could cause actual results to differ
include the possibility that our existing and new drug candidates may not
prove safe or effective, the possibility that our existing and new
applications to the FDA and other regulatory agencies may not receive approval
in a timely manner or at all, the possibility that our existing and new drug
candidates, if approved, may not be more effective, safer or more cost
efficient than competing drugs, the possibility that our efforts to acquire or
in-license and develop additional drug candidates may fail, our lack of
sustained revenue history, our limited marketing experience, our customer
concentration, the possibility for fluctuations in customer orders, evolving
market dynamics, our dependence on third parties for clinical trials,
manufacturing, distribution, information and quality control and other risks
that are described in further detail in the Company's reports filed with the
Securities and Exchange Commission. We do not plan to update any such
forward-looking statements and expressly disclaim any duty to update the
information contained in this press release except as required by law.

SPECTRUM PHARMACEUTICALS, INC.^®, FUSILEV^®, FOLOTYN^®, and ZEVALIN^® are
registered trademarks of Spectrum Pharmaceuticals, Inc and its affiliates.
REDEFINING CANCER CARE™ and the Spectrum Pharmaceuticals logos are trademarks
owned by Spectrum Pharmaceuticals, Inc. Any other trademarks are the property
of their respective owners.

© 2013 Spectrum Pharmaceuticals, Inc. All Rights Reserved.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(In thousands, except share and per share data)

(unaudited)
                                                         
                                                                  
                                             Three Months Ended

                                             March 31,
                                              2013               2012
Revenues:
Product sales, net                           $ 29,346             $ 56,784
License and contract revenue                  9,321              3,075
                                                                  
Total revenues                               $ 38,667            $ 59,859
                                                                  
Operating costs and expenses:
Cost of product sales (excludes
amortization of purchased                      6,782                8,673
intangible assets)
Selling, general and                           22,347               18,262
administrative
Research and development                       11,981               8,891
Amortization of purchased                     2,368              930
intangibles
                                                                  
Total operating costs and expenses            43,478             36,756
                                                                  
(Loss) income from operations                  (4,811     )         23,103
Other (expense) income, net                   (1,318     )        138
                                                                  
(Loss) income before provision for             (6,129     )         23,241
income taxes
Benefit from income taxes                     3,340              23,301
                                                                  
Net (loss) income                            $ (2,789     )       $ 46,542
                                                                  
Net (loss) income per share:
Basic                                        $ (0.05      )       $ 0.80
                                                                  
Diluted                                      $ (0.05      )       $ 0.71
                                                                  
Weighted average shares
outstanding:
Basic                                         58,181,380         58,464,059
                                                                  
Diluted                                       58,181,380         65,258,510
                                                                  

CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands)

(unaudited)
                                                        
                                                                  
                                                March 31,         December 31,

                                                2013              2012
                                                                  
Cash, cash equivalents                            160,073             139,698
Marketable securities                             3,310               3,310
Accounts receivable, net                          39,432              92,169
Inventories, net                                  16,618              14,478
Prepaid expenses and other current                3,126               2,745
assets
Tax asset                                        16,476             12,473
                                                                  
Total current assets                              239,035             264,873
Property and equipment, net                       2,227               2,548
Intangible assets, net                            206,593             202,311
Goodwill                                          28,904              28,973
Other assets                                     9,369              7,569
                                                                  
Total Assets                                    $ 468,128         $   506,274
                                                                  
                                                                  
                                                                  
Current liabilities                             $ 103,453         $   128,397
Deferred revenue and other credits –              3,456               2,937
less current portion
Deferred development costs – less                 11,337              11,377
current portion
Deferred payment contingency                      2,374               2,287
Other long-term liabilities                       6,130               1,430
Revolving line of credit                         75,000             75,000
                                                                  
Total liabilities                                 201,750             221,428
Total stockholders’ equity                       284,378            284,846
                                                                  
Total liabilities and stockholders’             $ 486,128         $   506,274
equity
                                                                  

Non-GAAP Financial Measures

In this press release, Spectrum reports certain historical and expected
non-GAAP results. Non-GAAP financial measures are reconciled to the most
directly comparable GAAP financial measure in the tables of this press release
and the accompanying footnotes. The non-GAAP financial measures contained
herein are a supplement to the corresponding financial measures prepared in
accordance with generally accepted accounting principles (GAAP). The non-GAAP
financial measures presented exclude the items summarized in the below table.
Management believes that adjustments for these items assist investors in
making comparisons of period-to-period operating results and that these items
are not indicative of the Company's on-going core operating performance.

Management uses non-GAAP net income (loss) in its evaluation of the Company's
core after-tax results of operations and trends between fiscal periods and
believes that these measures are important components of its internal
performance measurement process. Management believes that providing these
non-GAAP financial measures allows investors to view the Company's financial
results in the way that management views the financial results.

The non-GAAP financial measures presented herein have certain limitations in
that they do not reflect all of the costs associated with the operations of
the Company's business as determined in accordance with GAAP. Therefore,
investors should consider non-GAAP financial measures in addition to, and not
as a substitute for, or as superior to, measures of financial performance
prepared in accordance with GAAP. The non-GAAP financial measures presented by
the Company may be different from the non-GAAP financial measures used by
other companies.

Condensed Consolidated Statements of Operations and Reconciliation of Non-GAAP
Adjustments

(In thousands, except share and per share data)

(Unaudited)
                                         
                                               Three months ended

                                               March 31,
                                               2013           2012       
                                                                  
GAAP license and contract revenue              9,321              3,075
Non GAAP adjustments to license and
contract revenue:                              6,225             --         

Amendment of the Allergan agreement
Total adjustments to license and               6,225              --
contract revenues
Non-GAAP license and contract                  3,096             3,075      
revenue
                                                                  
GAAP selling, general and                      22,347             18,262
administrative expenses
Non GAAP adjustments to SG&A:
Reduction in staff                             --                 272
Stock-based compensation                       2,073              2,624
Allos tender offer and Bayer
agreement for licensing rights to              --                 830
market ZEVALIN outside the U.S.
Legal and professional fees for                336               --         
shareholder lawsuit
Total adjustments to SG&A                      2,409              3,726
Non-GAAP selling, general and                  19,938            14,536     
administrative
                                                                  
                                                                  
GAAP research and development                  11,981             8,891
Non-GAAP adjustments to R&D:
Stock-based compensation                       674                391
One-time payment for co-development            1,100             1,000      
agreement
Total adjustments to R&D                       1,774              1,391
Non-GAAP research and development              10,207            7,500      
GAAP amortization of purchased                 2,368              930
intangibles
Non-GAAP adjustments to purchased
intangibles:
Amortization                                   2,368             930        
Total adjustments to amortization of           2,368              930
purchased intangibles
Non-GAAP amortization of purchased             --                --         
intangibles
                                                                  
GAAP (loss) income before income               (6,129     )       23,241
taxes
Total non-GAAP adjustments                     326               6,047      
Non-GAAP income before income taxes            (5,803     )       29,288     
                                                                  
GAAP benefit for income taxes                  3,340              23,301
Adjustment to benefit for income               (957       )       (25,609    )
taxes
Non-GAAP benefit/(provision) for               2,383             (2,308     )
income taxes
                                                                  
GAAP net (loss) income                         (2,789     )       46,542
Non-GAAP adjustments                           (631       )       (19,562    )
Non-GAAP net income                            (3,420     )       26,980     
                                                                  


Non-GAAP income per share:
Basic                                          (0.06      )       0.46       
Diluted                                        (0.06      )       0.41       
                                                                  
Weighted average shares outstanding:
Basic                                          59,181,380        58,464,059 
Diluted                                        59,181,380        65,258,510 

Contact:

Spectrum Pharmaceuticals
Shiv Kapoor
Vice President, Strategic Planning & Investor Relations
702-835-6300
InvestorRelations@sppirx.com
 
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